A cross-sectional study of support services influencing patient enrollment decisions in clinical trials.

137 Background: Though clinical trial (CT) participation barriers are well-characterized, there’s limited evidence on strategies to overcome them. We conducted a cross-sectional study to assess the relative impact of specific support services on patients’ (pts) decision to enroll if offered a CT. Methods: We thematically categorized known CT participation barriers and mapped their corresponding pt support resources, reported publicly from sponsors, pt groups, and health systems to develop 4 survey items on pt’s perceived helpfulness of each resource on their trial participation decision (5-point Likert scale). After IRB approval, pts with current or prior lung cancer were recruited (12/30/24–1/10/25) via Lung Cancer Research Foundation & social media. Analysis included descriptive statistics, response grouping, and coding of free-text responses. Results: Overall, 314 pts with lung cancer completed the survey, 58% aged 40-64y, 37% 65y+, 6% AYA 18-39y; 78% were female, 62% had metastatic disease, 78% never participated in a CT. Four key thematic solutions with respective support services targeting CT access barriers were identified: Enhanced Expert Support: Over 90% of pts report having increased support from professionals—inc. access to CT team, frequent check-ins about symptoms, and personalized guidance from a trained trial navigator—would make them more likely to enroll. Pts 65y+ were more likely to enroll if given more opportunities to report symptoms (93% vs 82%, p 0.008). Cost-Informed Pt Engagement: Over 80% were more likely to consent if (1) told their expected out-of-pocket costs during CT participation for services not covered, (2) provided financial resources, inc. full medication coverage for side effects, travel for CT activities; 62% were more likely to consent if housing, gas, and meal costs were covered. Multi-Modal On-Demand Education: Over 80% were more likely to consent if provided on-demand education, inc. (1) video from the PI on side effects & management, esp. pts aged 65+ (87% vs 77% of pts < 65y, p 0.038); (2) one-pager on key CT aspects ( process, time commitment), esp. non-partnered pts (92% vs 79% for partnered pts, p 0.021). Over 70% also wanted a list of questions to ask their medical team, diagnosis info, and a video from the PI on CT design and consent process. Time-Conscious Pt Experience: Over 90% were more likely to consent if offered coordination of appointments/scans & increased flexibility with scheduling. Over 80% also ranked having video/ phone visits and optional blood draws at home/location of choice to be influential in consenting. Conclusions: Our findings highlight four key solutions that influence CT participation and offer actionable recommendations—such as expert support, clear education, and time/cost transparency—for sponsors, regulators, and others to proactively make CTs more accessible.

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Publication Details

Journal
JCO Oncology Practice
Published
2025-10-01
DOI
https://doi.org/10.1200/op.2025.21.10_suppl.137
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
0.00
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article

A cross-sectional study of support services influencing patient enrollment decisions in clinical trials.

Cardinale B. Smith, Eric Kumar Singhi, Robert Michael Daly, Ishwaria M. Subbiah et al.
JCO Oncology Practice
Health Systems, Economic Evaluations, Quality of Life
article

A cross-sectional study of support services influencing patient enrollment decisions in clinical trials.

Cardinale B. Smith, Eric Kumar Singhi, Robert Michael Daly, Ishwaria M. Subbiah, Andrea Arfè, Terri Conneran, Isabel R. Preeshagul, Jonathan M. Feldman, Marcia K. Horn, Devika Das, Mark M. Awad, Antoinette J. Wozniak
article en

Abstract

137 Background: Though clinical trial (CT) participation barriers are well-characterized, there’s limited evidence on strategies to overcome them. We conducted a cross-sectional study to assess the relative impact of specific support services on patients’ (pts) decision to enroll if offered a CT. Methods: We thematically categorized known CT participation barriers and mapped their corresponding pt support resources, reported publicly from sponsors, pt groups, and health systems to develop 4 survey items on pt’s perceived helpfulness of each resource on their trial participation decision (5-point Likert scale). After IRB approval, pts with current or prior lung cancer were recruited (12/30/24–1/10/25) via Lung Cancer Research Foundation & social media. Analysis included descriptive statistics, response grouping, and coding of free-text responses. Results: Overall, 314 pts with lung cancer completed the survey, 58% aged 40-64y, 37% 65y+, 6% AYA 18-39y; 78% were female, 62% had metastatic disease, 78% never participated in a CT. Four key thematic solutions with respective support services targeting CT access barriers were identified: Enhanced Expert Support: Over 90% of pts report having increased support from professionals—inc. access to CT team, frequent check-ins about symptoms, and personalized guidance from a trained trial navigator—would make them more likely to enroll. Pts 65y+ were more likely to enroll if given more opportunities to report symptoms (93% vs 82%, p 0.008). Cost-Informed Pt Engagement: Over 80% were more likely to consent if (1) told their expected out-of-pocket costs during CT participation for services not covered, (2) provided financial resources, inc. full medication coverage for side effects, travel for CT activities; 62% were more likely to consent if housing, gas, and meal costs were covered. Multi-Modal On-Demand Education: Over 80% were more likely to consent if provided on-demand education, inc. (1) video from the PI on side effects & management, esp. pts aged 65+ (87% vs 77% of pts < 65y, p 0.038); (2) one-pager on key CT aspects ( process, time commitment), esp. non-partnered pts (92% vs 79% for partnered pts, p 0.021). Over 70% also wanted a list of questions to ask their medical team, diagnosis info, and a video from the PI on CT design and consent process. Time-Conscious Pt Experience: Over 90% were more likely to consent if offered coordination of appointments/scans & increased flexibility with scheduling. Over 80% also ranked having video/ phone visits and optional blood draws at home/location of choice to be influential in consenting. Conclusions: Our findings highlight four key solutions that influence CT participation and offer actionable recommendations—such as expert support, clear education, and time/cost transparency—for sponsors, regulators, and others to proactively make CTs more accessible.

JCO Oncology PracticeVol. 21(10_suppl)
Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), University of Florida (US), Lung Cancer Research Foundation (US)
Openalex Percentile: Top 63%
Health Systems, Economic Evaluations, Quality of Life
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